Functional and histological improvement after everolimus rescue of chronic allograft dysfunction in renal transplant recipients

Figures & data

Figure 1 Diagram of patient disposition.

Table 1 Baseline demographic characteristicsa

Characteristics	Results
Age (years)	46±9
Female sex	5 (29.4%)
Body weight (kg)	65.8±13.2
Body mass index (kg/m^2)	23.6±3.8
Primary cause of end-stage renal disease
Glomerular disease/glomerulonephritis	11 (64.7%)
Interstitial nephritis	1 (5.9%)
Unknown	5 (29.4%)
Duration of renal transplant (months)b	50 (16.5–140)
Deceased donor	13 (76.5%)
Number of HLA mismatch	1.7±1.5
Previous number of biopsy-proven	0 (0–0.5)
acute rejection episodesb
Baseline serum creatinine (μmol/L)	168.9±34.6
Immunosuppression at recruitment
Corticosteroid	17 (100%)
Cyclosporine	17 (100%)
Azathioprine	13 (76.5%)
Mycophenolate mofetil	2 (11.8%)
Cyclosporine dose (mg/kg/day)	2.58±0.80
Cyclosporine 2-hour post-dose level (ng/mL)	660.5±132.5
Number of anti-hypertensive medications	2.0±1.2
Systolic blood pressure (mmHg)	127±14
Diastolic blood pressure (mmHg)	75±9
Concomitant medication at recruitment
Angiotensin converting enzyme inhibitor	8 (47.1%)
Angiotensin receptor blocker	2 (11.8%)
HMG-CoA reductase inhibitor	4 (23.5%)

Notes:

a Plus-minus values are mean ± SD unless otherwise indicated.

b Median (IQR) months.

Abbreviations: HMG-CoA, 3-hydroxy-3-methylglutaryl-coenzyme A; HLA, human leukocyte antigen; IQR, interquartile range.

Figure 2 Slope of renal function decline for individual patients before and after everolimus treatment.

Notes: Open circles denote average estimated glomerular filtration rate (GFR) of the whole group 12 months before treatment, at the time when treatment started, and 12 months after treatment. Error bars denote standard deviation.

Table 2 Change in glomerular filtration rate decline before and after everolimus therapy, as estimated by different prediction equations

Prediction equations for glomerular filtration rate	Slope of glomerular filtration rate over time during the 12-month period before study entry	Slope of glomerular filtration rate over time during the 12-month period on everolimus treatment	P-value
Nankivell	−4.31±6.65	1.29±5.84	0.036
MDRD	−4.00±5.20	0.84±5.44	0.028
CKD-EPI	−4.43±5.60	0.83±5.76	0.025

Note: Plus-minus values are mean ± SD.

Abbreviations: MDRD, Modification of Diet in Renal Disease Study; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration.

Figure 3 Histological scores of tubular atrophy before and after everolimus.

Figure 4 Histological scores of interstitial fibrosis before and after everolimus.

Table 3 Secondary clinical end points and parameters after everolimus therapy

Parameters	At study entry	At 12 months after everolimus treatment	P-value
Glomerular filtration rate estimated by Nankivell formula (mL/min/1.73 m^2)	58.0±14.0	60.1±18.0	0.24
Mean total cholesterol level (mmol/L)	5.5±1.0	6.0±0.9	0.13
Mean serum LDL cholesterol level (mmol/L)	3.0±0.9	3.3±0.8	0.39
Mean triglyceride level (mmol/L)	1.9±0.5	2.0±0.5	1.00
Number of patients (%) receiving HMG-CoA reductase inhibitor	4 (23.5%)	9 (52.9%)	0.08
Mean proteinuria (g/day)	0.16±0.24	0.31±0.46	0.07
Mean arterial pressure (mmHg)	93±9	92±11	0.79
Number of patients (percentage) receiving angiotensin converting enzyme inhibitor or angiotensin receptor blocker	9 (52.9%)	11 (64.7%)	0.49
Mean hemoglobin level (g/dL)	10.6±1.3	10.9±1.6	0.50

Note: Plus-minus values are mean ± SD unless otherwise indicated.

Abbreviations: HMG-CoA, 3-hydroxy-3-methylglutaryl-coenzyme A; LDL, low-density lipoprotein.